Manufacturing problems trigger another clinical hold for troubled Covid-19 vaccine — latest in a string of roadblocks
Just days after the World Health Organization suspended the use of Covaxin after a manufacturing site failed an inspection, the FDA has followed up with a clinical hold on the Covid-19 vaccine’s US co-developer.
Details are in short supply, but the manufacturing site run by Bharat Biotech in India is at the center of the issue after being cited for “deficiencies.” On Tuesday morning, Bharat Biotech’s partner Ocugen reported US regulators had placed a hold on the shot’s Phase II/III study. Bharat Biotech developed the shot and licensed it to Ocugen to co-develop it in the US and Canada.
At the start of April, the World Health Organization suspended its supply of Covaxin, known in the US as BBV-152, through the United Nations, after inspectors took issue with the Indian manufacturing facilities of Bharat Biotech.
“This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited’s manufacturing facility,” Ocugen said in a statement. “We will work with the FDA to address any questions.”
An inactivated virus-based vaccine, Covaxin has been in use in India since early 2021. It’s also been authorized in about a dozen other countries — and the WHO endorsed it for emergency use late last year. Based on Phase III data from India, unveiled in June, the shot was almost 78% effective at preventing disease.
Ocugen has long planned a Phase II/III immunobridging and booster trial in the US in order to bring it stateside. But in November, the FDA issued a clinical hold on the IND, with few details released. That was lifted in February.
It also submitted a request to the FDA for emergency use in children above the age of 2 in November, but the request was denied in March.
But just a few days ago, the WHO suspended the supply of Covaxin from the UN until “appropriate actions” were taken to address manufacturing practices that weren’t up to code with current GMP standards. The WHO did clarify that there were no safety or efficacy issues with the vaccine.
That announcement followed just a day after Bharat said it would scale back production of the vaccine, following a decrease in demand that coincided with a reduced number of infections and hospitalized patients.
Bharat had already turned to other vaccine makers — such as animal vaccine maker Hester Biosciences — to help ramp up production at the start of its efforts.
Ocugen’s stock $OCGN sank 9% on the news in November, but bounced back almost 7% in pre-market trading days later.
Shares were trading around $2.72 Tuesday morning, down about $1 from about a month ago. That’s a far cry away from the high of $15.67 in which it was trading before the first clinical hold in November.